New migraine pill aims to stop pain in 2 hours – major trial underway

NCT ID NCT07645924

Symptom relief Sponsor: Kallyope Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 13 times

Summary

This study tests a new drug, elismetrep, to see if it can quickly stop migraine pain and bothersome symptoms like nausea or light sensitivity. About 1800 adults with frequent migraines will receive either the drug or a placebo. The main goal is to measure how many people are pain-free within 2 hours of taking the medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1\. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements: a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following: 1. A minimum of 12 months of spontaneous amenorrhea or 2. A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level \> 40 mIU/mL or 3. At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit. Acceptable methods of birth control are: 1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal). 2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable). 3. Intrauterine device (IUD); 4. Intrauterine hormone-releasing system (IUS); 5. Bilateral tubal occlusion; 6. Vasectomized partner; 7. Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; 8. Male or female condom with or without spermicide; 9. Cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods). 5\. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study. Exclusion Criteria: Participants are excluded from the trial if any of the following criteria apply: 1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial. Migraine history-related 2. Has difficulty distinguishing his/her migraine attacks from tension-type headaches. 3. Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours. 4. Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1). 5. Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine. 6. Was \>50 years old at age of first migraine onset. 7. Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening. Medical history related 8. Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine \[Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study\]. 9. Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 2 months or suicidal behavior in the past 6 months. 10. Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results. 11. Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care. 12. Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening. 13. Has a history of human immunodeficiency virus disease. 14. Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption or may otherwise alter the absorption of orally administered drugs (e.g. upper gastrointestinal dysmotility). Laboratory, vital sign, and electrocardiogram related 15. Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody. 16. Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of \<30 mL/min/1.73 m2. 17. Has a screening result for alanine aminotransferase or aspartate aminotransferase of \>2.0 X upper limit of normal (ULN) or total bilirubin \>1.5 X ULN at the Screening visit. Note: An isolated bilirubin \>1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range. 18. Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) \>450 ms for males and \>470 ms for females at screening. 19. Has a mean value for triplicate seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes. Medication use and substance abuse related 20. Has known history of or suspected abuse of alcohol or recreational drugs at Screening. 21. Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol \[THC\] or cannabidiol \[CBD\] within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to screening. 22. Has a positive drug screen at screening. Note: 1. If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician. 2. If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used. 23. Is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during study participation (detailed in the protocol). Note: Any use of the following within 8 weeks of the screening visit, or anticipated use at any point during study participation are exclusionary: 1. Devices for the acute and/or preventative treatment of headache (migraine and/or other type of headache) 2. Nerve blocks and/or trigger point injections for the acute and/or preventative treatment of headache (migraine and/or other type of headache). 24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation. 25. Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening. 26. Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening. Other 27. Has known or suspected hypersensitivity to trial product(s) or related products. 28. Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food. 29. Has any surgery scheduled for the duration of the trial. 30. Has a screening hemoglobin \<11.0 g/dL (males) or \<10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia). 31. Has previous participation in this trial. Participation is defined as signed informed consent. 32. Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P004. Note: Patients may not be screened at more than one trial site for this study. 33. Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results. 34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

113 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AMR Clinical - Kansas City
RECRUITING

Kansas City, Missouri, 64114, United States
AMR Clinical - Las Vegas
RECRUITING

Las Vegas, Nevada, 89119, United States
AMR Clinical - Lexington
RECRUITING

Lexington, Kentucky, 40509, United States
AMR Clinical - Norfolk
RECRUITING

Norfolk, Virginia, 23502, United States
AMR Mobile
RECRUITING

Mobile, Alabama, 36608, United States
APD Clinical Research
RECRUITING

Cypress, Texas, 77372, United States
Access Clinical Trials, Inc
RECRUITING

Nashville, Tennessee, 37203, United States
Acclaim Clinical Research
RECRUITING

San Diego, California, 92120, United States
Advanced Neurosciences Research
RECRUITING

Fort Collins, Colorado, 80528, United States
Advanced Research Institute
RECRUITING

Ogden, Utah, 84405, United States
Advanced Research Institute - Portland
RECRUITING

Portland, Oregon, 97223, United States
Advanced Research Institute - Reno
RECRUITING

Reno, Nevada, 89511, United States
Aim Trials, LLC
RECRUITING

Plano, Texas, 75093, United States
Albuquerque Clinical Trials
RECRUITING

Albuquerque, New Mexico, 87102, United States
Arkansas Clinical Research
RECRUITING

Little Rock, Arkansas, 72205, United States
Artemis Institute for Clinical Research
RECRUITING

Riverside, California, 92503, United States
Axiom Research, LLC
RECRUITING

Colton, California, 92324, United States
Axiom Research, Orange County
RECRUITING

Irvine, California, 92604, United States
Boston Clinical Trials - Alcanza
RECRUITING

Boston, Massachusetts, 02131, United States
CTI Clinical Research Center
RECRUITING

Lexington, Kentucky, 45212, United States
Carolina Research Center, Inc
RECRUITING

Shelby, North Carolina, 28150, United States
Cedar Crosse Research Center
RECRUITING

Chicago, Illinois, 60607, United States
CenExel Sherman Oaks CA (California Neuroscience Research)
RECRUITING

Sherman Oaks, California, 91403, United States
Central New York Clinical Research
RECRUITING

Manlius, New York, 13104, United States
Central Research Associates, LLC (CRA) dba Flourish Research
RECRUITING

Birmingham, Alabama, 35205, United States
Chase Medical Research, LLC
RECRUITING

Waterbury, Connecticut, 06708, United States
Chicago Headache Center & Research Institute
RECRUITING

Chicago, Illinois, 60657, United States
Chicago Headache Center & Research Institute
RECRUITING

Naperville, Illinois, 60563, United States
CincyScience
RECRUITING

West Chester, Ohio, 45069, United States
Clinical Associates Midwest, LLC
RECRUITING

Overland Park, Kansas, 66214, United States
Clinical Investigation Specialists, Inc.
RECRUITING

Kenosha, Wisconsin, 53144, United States
Clinical Research Associates, Inc.
RECRUITING

Nashville, Tennessee, 37203, United States
Clinical Research Institute
RECRUITING

Los Angeles, California, 90048, United States
Clinical Research Institute
RECRUITING

Minneapolis, Minnesota, 55402, United States
Clinical Research Philadelphia
RECRUITING

Philadelphia, Pennsylvania, 19114, United States
Clinpoint Trials
RECRUITING

Waxahachie, Texas, 75165, United States
Clinvest Headlands LLC
RECRUITING

Springfield, Missouri, 65807, United States
Coastal Carolina Research Center
RECRUITING

North Charleston, South Carolina, 29405, United States
Collective Medical Research
RECRUITING

Overland Park, Kansas, 66212, United States
Crescent City Headache & Neurology Center
RECRUITING

Chalmette, Louisiana, 70043, United States
DM Clinical Research
RECRUITING

Houston, Texas, 77081, United States
DelRicht Research
RECRUITING

Atlanta, Georgia, 30329, United States
DelRicht Research
RECRUITING

New Orleans, Louisiana, 70115, United States
DelRicht Research
RECRUITING

Gulfport, Mississippi, 39503, United States
DelRicht Research
RECRUITING

Tulsa, Oklahoma, 74133, United States
Dent Neuro Institute, Buffalo
RECRUITING

Amherst, New York, 14226, United States
Diablo Clinical Research
RECRUITING

Walnut Creek, California, 94598, United States
Downtown L.A. Research Center, Inc.
RECRUITING

Los Angeles, California, 90017, United States
Drug Studies America
RECRUITING

Marietta, Georgia, 30060, United States
Empire Clinical Research
RECRUITING

Pomona, California, 91767, United States
Encompass Clinical Research
RECRUITING

Spring Valley, California, 91978, United States
Excel Clinical Research
RECRUITING

Las Vegas, Nevada, 89109, United States
Excell Research
RECRUITING

Oceanside, California, 92056, United States
Eximia Research - NC, LLC
RECRUITING

Raleigh, North Carolina, 27607, United States
Fieve Clinical Research, Inc
RECRUITING

New York, New York, 10017, United States
Focus Clinical Research
RECRUITING

West Hills, California, 91307, United States
Frontier Clinical Research
RECRUITING

Morgantown, West Virginia, 26505, United States
Frontier Clinical Research, LLC
RECRUITING

Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research, LLC
RECRUITING

Smithfield, Pennsylvania, 15478, United States
FutureSearch Trials of Dallas, LP
RECRUITING

Dallas, Texas, 75251, United States
FutureSearch Trials of Neurology
RECRUITING

Austin, Texas, 78731, United States
GMG Clinical Research, LLC dba Radiance Clinical Research
RECRUITING

Lampasas, Texas, 76550, United States
Granger Medical Clinic
RECRUITING

Riverton, Utah, 84096, United States
Guildford Neurologic Research Partners, LLC
RECRUITING

Greensboro, North Carolina, 27405, United States
Headache Wellness Center
RECRUITING

Greensboro, North Carolina, 27405, United States
Headlands Research - PharmaSite
RECRUITING

Pikesville, Maryland, 21208, United States
Health Research of Hampton Roads, Inc. (HRHR)
RECRUITING

Newport News, Virginia, 23606, United States
Healthcare Research Network
RECRUITING

Hazelwood, Missouri, 63042, United States
Healthcare Research Network II, LLC
RECRUITING

Flossmoor, Illinois, 60477, United States
Heartland Research Associates, LLC - An AMR Company
RECRUITING

Wichita, Kansas, 67207, United States
Hightower Clinical
RECRUITING

Oklahoma City, Oklahoma, 73102, United States
Hometown Research
RECRUITING

Columbus, Ohio, 43228, United States
Hometown Research
RECRUITING

Milford, Ohio, 45150, United States
Horizon Clinical Research and Gill Neuroscience
RECRUITING

Cypress, Texas, 77429, United States
IMA Clinical Research - Las Vegas
RECRUITING

Las Vegas, Nevada, 89102, United States
IMMUNOe Research Centers
RECRUITING

Centennial, Colorado, 80112, United States
Integrated Clinical Trials Solution
RECRUITING

West Des Moines, Iowa, 50265, United States
J. Lewis Research, Inc. / Foothill Family Clinic
RECRUITING

Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic
RECRUITING

Salt Lake City, Utah, 84121, United States
J. Lewis Research, Inc. / Foothill Family Clinic Draper
RECRUITING

Draper, Utah, 84020, United States
Kinetic Clinical Research
RECRUITING

West Covina, California, 91790, United States
Las Vegas Clinical Trials
RECRUITING

North Las Vegas, Nevada, 89030, United States
Leading Edge Research LA, LLC
RECRUITING

Encino, California, 91316, United States
Lehigh Center for Clinical Research
RECRUITING

Allentown, Pennsylvania, 18103, United States
M3 Wake Research - Mission Mental Health (WR-MMH)
RECRUITING

Mission Viejo, California, 92691, United States
MCB Clinical Research Centers
RECRUITING

Colorado Springs, Colorado, 80910, United States
MedVadis Research Corporation, LLC
RECRUITING

Waltham, Massachusetts, 02451, United States
Michigan Headache Pain & Neurological Institute
RECRUITING

Ann Arbor, Michigan, 48104, United States
OK Clinical Research, LLC
RECRUITING

Edmond, Oklahoma, 73034, United States
OnSite Clinical Solutions
RECRUITING

Charlotte, North Carolina, 28277, United States
Pantheon Clinical Research
RECRUITING

Bountiful, Utah, 84010, United States
Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
RECRUITING

Bardstown, Kentucky, 40004, United States
Preferred Primary Care Physicians, Inc.
RECRUITING

Pittsburgh, Pennsylvania, 15236, United States
ProScience Research Group
RECRUITING

Culver City, California, 90230, United States
Proven Endpoints
RECRUITING

Ridgeland, Mississippi, 39157, United States
Redbird Research
RECRUITING

Las Vegas, Nevada, 89119, United States
Rochester Clinical Research
RECRUITING

Rochester, New York, 14609, United States
SPRI Clinical Trials, LLC
RECRUITING

Brooklyn, New York, 11235, United States
Seattle Clinical Research Center
RECRUITING

Seattle, Washington, 98104, United States
Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
RECRUITING

Stockbridge, Georgia, 30281, United States
StudyMetrix Research
RECRUITING

City of Saint Peters, Missouri, 63303, United States
Summit Research Network
RECRUITING

Portland, Oregon, 97210, United States
Sundance Clinical Research
RECRUITING

St Louis, Missouri, 63141, United States
Sunwise Clinical Research
RECRUITING

Walnut Creek, California, 94596, United States
Tekton Research
RECRUITING

Austin, Texas, 78745, United States
Tekton Research, Inc.
RECRUITING

Yukon, Oklahoma, 73099, United States
The Neurology Group
RECRUITING

Pomona, California, 91767, United States
TrialSphere
RECRUITING

Chandler, Arizona, 85286, United States
True North Neurology
RECRUITING

Commack, New York, 11725, United States
Upstate Clinical Research Associates
RECRUITING

Williamsville, New York, 14221, United States
Victorium Clinical Research
RECRUITING

Houston, Texas, 77024, United States
WR-ClinSearch, LLC
RECRUITING

Chattanooga, Tennessee, 37421, United States
Wake Research Las Vegas Rainbow
RECRUITING

Las Vegas, Nevada, 89118, United States

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